Cooper Health System IRB
Form 483 issued December 4, 2025
- Inspection
- Dec 1 – Dec 4, 2025
- Investigator
- Gabrielle J. Swain
- Observations
- 4
- Pages
- 3
- FEI number
- 2243630
In short: On December 4, 2025, FDA issued a Form 483 with 4 observations to Cooper Health System IRB (FEI 2243630) after an inspection that ran Dec 1 – Dec 4, 2025. The investigator was Gabrielle J. Swain. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 56.108 (iRB functions and operations).
At a glance
4 of 4 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 56.108 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The IRB has no written procedure for determining which projects require review more often than annually…
- 02
The IRB has no written procedure for reporting its findings and actions to…
- 03
The IRB has no written procedure for conducting its…
- 04
The IRB has no written procedures for ensuring prompt reporting to appropriate institutional officials and the…
This inspection in context
Questions about this 483
What did FDA find at Cooper Health System IRB?
FDA listed 4 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 56.108 (iRB functions and operations). The opening words of each observation are shown on this page.
Who inspected Cooper Health System IRB?
Gabrielle J. Swain is named on this Form 483, for the inspection of Dec 1 – Dec 4, 2025. Each investigator has a profile showing what they cite most.
When was Cooper Health System IRB inspected by FDA?
The inspection ran Dec 1 – Dec 4, 2025, and the Form 483 is dated December 4, 2025.
How do I get the full Form 483 for Cooper Health System IRB?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.